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NEWSLETTER
AUGUST 2014
 
 
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FOUNDATION NEWS

Symposium Survey, Keynote Speakers, and Early Bird Registration
Summer 2014 Global Perspective
2014 Summer Interns
Regulatory Barriers Report

RESEARCH NEWS
Swedish's Brain Program Excels
Investigator Profile: Paul Dayton, PhD
Local Media Touts UVA's Breast Tumor Study
Research Roundup

INDUSTRY NEWS
EDAP's FDA Hearing and Foundation Commentary
Celsion's $1M Brain Tumor Research Grant
FDA National Medical Device Curriculum

MEDIA COVERAGE
US Chamber blogs on focused ultrasound and more…

EVENTS

September 14-17 ASTRO
September 18-20 SMIT
October 6-8 AdvaMed
October 10-11 Interventional MRI
October 12-16 FUSF Symposium
October 29 MJFF Therapeutics
 
First Pediatric Bone Tumor Patient Treated with Focused Ultrasound in North America
  Jack with his parents and Dr. James Drake, Lead of the Centre for Image-Guided Innovation and Therapeutic Intervention at SickKids
 
Jack Campanile, a 16-year-old Canadian boy, is the first patient treated in a clinical trial being conducted by The Hospital for Sick Children (SickKids) using the Philips Sonalleve system at Sunnybrook Health Sciences Centre in Toronto.

The team used focused ultrasound to destroy a benign bone tumor located in Jack's femur, providing quick relief from the intractable pain that required around-the-clock medication.

 

This treatment is part of a study funded by the Focused Ultrasound Foundation and the SickKids Foundation to evaluate the feasibility, safety, and preliminary efficacy of the technology in treating osteoid osteoma, an extremely painful, but benign, bone tumor in children and young adults. The Focused Ultrasound Foundation is supporting a total of 20 pediatric treatments at SickKids and two additional research sites.

"With high-intensity focused ultrasound, we are moving from minimally-invasive to non-invasive therapy, significantly reducing risk to the patient and fast-tracking recovery," says SickKids interventional radiologist Dr. Michael Temple, who led the team that performed the surgery.

"We are extremely excited about the potential of focused ultrasound to free kids from their pain and get them back to their active healthy lives," said Neal F. Kassell, MD, Chairman of the Focused Ultrasound Foundation. "This study fits perfectly with our mission to invest donor dollars to accelerate access to focused ultrasound for patients in need like Jack."

WATCH THE INSPIRING INTERVIEW WITH JACK AND HIS PARENTS ►

SEE THE SICKKIDS PRESS RELEASE AND NEWS COVERAGE ►

WATCH DR. TEMPLE'S LABORATORY DEMO ►

 
  FOUNDATION NEWS  
 

Early Bird registration ends soon!

 
Symposium Team Seeks Your Insight


How will focused ultrasound benefit the largest number of patients? Which bioeffects have the most therapeutic value? What are the remaining barriers to commercial success? We Need Your Insight!



As we prepare for our Symposium, we want to hear from researchers, clinicians, industry leaders and others on the front lines of focused ultrasound technology. Results will be shared at the Symposium.

Our October Symposium offers multifaceted exploration of current and future applications of the technology via plenary sessions, panel discussions, poster presentations, and exhibits. Register online now and save up to $100.

 
 
 

von Eschenbach

Hamilton

 

 
2014 Symposium: Andrew von Eschenbach and Rick Hamilton to Shine Spotlight on Innovation


Two champions of innovation, Andrew von Eschenbach, MD, and Rick Hamilton, will deliver keynote addresses at the Symposium, applying their unique experiences to the opportunities for and future of focused ultrasound. The pair joins device entrepreneur Frederic Moll, MD, to round out the Symposium's headliners.

Dr. von Eschenbach is the only person to have led both the US Food and Drug Administration (FDA) and the National Cancer Institute (NCI). Rick Hamilton, IBM's Cloud Offering Evangelist and Master Inventor, is an innovation authority and the company's most prolific inventor, holding more than 550 US patents.

"Discovery research has led to astounding breakthroughs in our understanding the mechanisms of disease. That emerging knowledge is being rapidly translated into innovative technologies that can help restore health. Focused ultrasound exemplifies such progress as it pioneers the application of physical energy to modulate biology."
– Andrew von Eschenbach, MD

READ MORE ►

 
 
 

 
Global Perspective Report Provides Technology Overview


The Foundation has published its Summer 2014 Focused Ultrasound Global Perspective report, a comprehensive overview of the state of the technology, including facts and figures on:

  • approved indications
  • manufacturers
  • research centers
  • treatment sites

This bi-annual report enables academia, government, industry, and investors to monitor progress in the field.

 

The summer interns include students from six universities

 
2014 Summer Interns Contribute to Foundation Research


In its third year, the Foundation's summer internship program welcomed a record 12 students to collaborate with the Foundation staff. With so many hands on deck, many teamed up to tackle more complicated projects.

"This year's group of summer interns made great contributions to research," says the Foundation's Director of Extramural Research, Matt Eames, PhD. "Their work resulted in a publication submission, and many will join us at the Symposium to present their work. The Foundation team enjoys guiding these students, and we feel energized by their fresh insight into some complex projects."

The 2014 program was generously funded by the Claude Moore Charitable Foundation. "The Claude Moore Summer Internships support our mission to cultivate the next generation of researchers," said the Foundation's Director of Development, Pamela Minetti.

READ MORE ABOUT EACH INTERN AND THEIR PROJECT ►

 

Graduate Intern Liz Dobrenz wrote a report assessing regulatory barriers for focused ultrasound

 
Regulatory Barriers: Report Affirms Foundation Strategy


One role of the Foundation is to maintain communication with the US Food and Drug Administration (FDA) to enhance their understanding of focused ultrasound (FUS), confer on standards of assessment, and optimize regulatory opportunities.

FUS devices must pass FDA's most rigorous device review process before reaching the market. Since FUS is still a relatively new technology, new devices require extensive scientific review to ensure safety and effectiveness before receiving FDA approval. This spring, a FUS Foundation Graduate Intern assessed the current device classification and the feasibility of reclassifying the technology to reduce time to market for FUS devices. The report concludes that it will take many years to build the clinical experience and data for the technology to be reclassified. In the meantime, the report recommends the Foundation continue to foster discussions about regulation of FUS, increase direct-to-FDA advocacy, and support regulatory science projects.
 

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  RESEARCH NEWS  
 

Stephen Monteith, MD and David Newell, MD

"We're proud to be researching a treatment that could one day bring new hope to improving the quality of life for patients"
– Ryder Gwinn, MD, Principal Investigator

 

 

Swedish's Focused Ultrasound Brain Program Excels

Institute now studying Essential Tremor, Parkinson's, and Tumors

Swedish Neuroscience Institute (SNI) in Seattle is quickly becoming one of the leading brain research centers in the world for focused ultrasound.

SNI recently announced that they have joined an ongoing study at the University of Virginia to assess focused ultrasound to treat tremor associated with Parkinson's disease. Additionally, a new trial at SNI will examine whether focused ultrasound could help contain brain tumor growth and allow for more time between additional therapies compared to stereotactic radiosurgery and chemotherapy.

Patients who are interested in finding out more about these studies should contact SNI at (206) 320-3070 or

"SNI is one of the few locations in the world where focused ultrasound is being studied at this level. These efforts exemplify our ongoing mission to deliver leading edge treatment for brain and spinal conditions. We are honored to be a pioneer in this field and are eager to produce translational results," said David Newell, MD, Chief of Neurosciences. Foundation Chairman Neal F. Kassell, MD, agrees: "We are privileged to have Swedish Neuroscience Institute advance the use of focused ultrasound in this region."

The SNI team has been participating in the Essential Tremor Study since the summer of 2013. A story about the Institute's work aired yesterday on HealthLink, the health news segment of their local NBC affiliate, KING-5.


 

Paul Dayton, PhD



 

 

Nanodroplets May Significantly Reduce Focused Ultrasound Procedure Times

Scientist Discusses his Promising Foundation-Funded Research

North Carolina scientist Paul Dayton, PhD is in the final stages of a Foundation-funded study on the use of nanodroplets to improve the efficiency of focused ultrasound ablation.

Our new Investigator Profile series highlights Foundation-funded research and the experts who are leading the way in developing focused ultrasound

The nanodroplets assessed in the preclinical study were able to rapidly increase heating by more than 25 degrees Celsius at the target without peripheral heating. The results suggest that their nanodroplets are sufficiently stable to enhance FUS ablation for at least 1.5 hours, avoid skin burns, and are a better option over microbubbles. These nanodroplets could potentially reduce FUS procedure times by as much as five-fold by more quickly ablating a larger region of tissue without compromising safety.

READ A Q&A ABOUT THE PROJECT AND HOW DR. DAYTON THINKS NANODROPLETS MAY ONE DAY FACILITATE FUS TREATMENT OF CANCER ►


 

Dr. David R. Brenin and Dr. Carrie Rochman are studying focused ultrasound treatment of benign breast tumors

 

 

Local Media Touts UVA's Breast Tumor Study


According to a new press release, University of Virginia (UVA) researchers are now actively looking for women with benign breast tumors (called fibroadenomas) to participate in their focused ultrasound study.

WVIR-29, the local NBC affiliate, reported the story. In their interview, UVA radiologist Dr. Carrie Rochman said, "We're using the ultrasound machine to guide us to the mass and the same ultrasound machine to then focus the energy at enough power that it destroys the tumor from within. So the end result is no scar for a patient."

Patients who are interested in learning more about the study should contact Katie Rea, RN, clinical research coordinator, at (434) 243-0315.


 

 

 

Research Roundup


Recent focused ultrasound research covers a variety of applications. In oncology, two interesting studies looked at pancreatic cancer (safety and a comprehensive case review), and one discovered improved outcomes for localized prostate cancer. Cavitation-induced thrombolysis work is gaining ground, and another group provides cost-effectiveness data for uterine fibroid ablation.

READ MORE ►


 


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  INDUSTRY NEWS  
 

"The bar for approval in this low risk population is high based on the long-term scientific evidence required for effectiveness. Despite this recent result, many US patients are not happy with their current options and are waiting for less invasive alternatives."
– Jessica Foley, the Foundation's Scientific Director

 

 

EDAP's FDA Hearing: Panel Does Not Recommend Approval


On July 30th, a US Food and Drug Administration advisory panel met to review data and vote on whether to recommend approval of EDAP-TMS's Ablatherm focused ultrasound system for the treatment of low risk prostate cancer. The panel voted that the risk of the treatment was too high for the limited efficacy demonstrated, that there is not reasonable assurance that the system is effective, and that the benefits do not outweigh the risks based on the evidence presented.

Not surprisingly, EDAP's leadership is disappointed with the ruling, and issued a full statement in response, including these points:

  • Ablatherm-HIFU has a proven safety record through its approval and use in Europe, Canada, Russia, Brazil, Mexico, and South Korea.
  • Ablatherm has treated more than 40,000 prostate cancer patients worldwide since its initial CE Mark approval in 2000.
  • The French Ministry of Health recently approved HIFU reimbursement for primary care patients at the same level as surgery.
  • The Panel seemed to agree that the current approval path for new treatments for low risk prostate cancer is prohibitive and that existing therapies, if evaluated on today's requirements, would be unlikely to qualify for a positive vote.
A flurry of news coverage followed the hearing, and can be read here.

 

 

Foundation Chairman Neal F. Kassell, MD

"What this dilemma highlights is the tremendous need to have a diagnostic test that can differentiate those patients with low grade prostate cancer whose tumors pose a threat that should be treated from those whose tumors will not be a problem."

 

 

Commentary: Putting the FDA Panel's Feedback Into Perspective


Last month, the FDA advisory panel made a highly unfortunate ruling that, based on data presented by EDAP, there is not reasonable assurance that the Ablatherm focused ultrasound device is safe and effective for the treatment of low risk localized prostate cancer. The device has been approved in Europe since 1999, and 40,000 patients around the world have been treated with the system to date.

It is important to keep in mind that the overarching issue is with the patient population and the study design, and not the focused ultrasound technology. Pragmatically, the burden is very high for a clinical trial to demonstrate an improvement in outcome in patients with low risk prostate cancer, whether the treatment is focused ultrasound, cryotherapy, radiotherapy, etc. As noted by a panel member, thousands of men would have to be followed for 30 years to prove efficacy. In addition, EDAP had significant difficulty recruiting for the cryotherapy control arm, having to change their study plans after five years of trying to enroll patients.

The problem confronting the urological community is that there are a substantial number of patients who are not comfortable with the watchful waiting paradigm after they are diagnosed with low-grade prostate cancer. An increasing number of these patients who have the financial wherewithal are seeking treatment outside of the United States. The vexing issue is how to reconcile the disconnect between the desire of patients to be treated with a lack of availability of the technology in the US due to regulatory hurdles...

READ MORE ►

 

 

 

 

BWH and HMS Researcher in collaboration with Celsion Gets $1M NIH Grant to Study the Use of Thermadox for Brain Tumors


Last month, Celsion Corporation announced that Dr. Costas Arvanitis of Brigham and Women's Hospital and Harvard Medical School has been awarded a $1 million Career Development Award from the NIH Center for Biomedical Imaging and Bioengineering. The grant, titled "Controlled Delivery and Release of Chemotherapy in Brain Tumors with Focused Ultrasound" will be used for preclinical studies to evaluate Celsion's heat-activated liposomal encapsulation of doxorubicin (ThermoDox®) in combination with focused ultrasound for the treatment of brain tumors.

 

 

 

 

National Medical Device Curriculum Aims to Spur Medtech Development


The US Food and Drug Administration has developed a National Medical Device Curriculum (NMDC) to educate students, entrepreneurs, and scientists about the agency's process for evaluating medical devices. NMDC is now available online and currently includes these four areas:

  • Regulatory Pathways for Medical Devices: Choosing the Right One
  • Freedom From Unacceptable Risk: Making a Case for Safety Assurance and Risk Management
  • Bringing an Innovative Device to Market: Premarket Approval (PMA) of Medical Devices
  • An Innovative "Me-Too" Idea: Premarket Notification - 510(k) Medical Device Submissions
 

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  MEDIA COVERAGE  
 

US Chamber of Commerce Features Two Blog Posts on Focused Ultrasound: Operation Disruption: New Ultrasound Technology Means Surgery With No Cuts on 8/4/14 and Big Data, Tear Down This Wall on 8/5/14.

SonaCare Medical Announces Platinum Sponsorship of 7th International Symposium on Focal Therapy and Imaging in Prostate & Kidney Cancer on Virtual Strategy.com 8/15/14


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  EVENTS  


UPCOMING MEETINGS

September 14-17, 2014 56th Annual Meeting of the American Society of Radiation Oncology (ASTRO), San Francisco, CA

September 18-20, 2014 26th International Conference of the Society for Medical Innovation and Technology (SMIT), Shanghai, China

October 6-8, 2014 AdvaMed 2014 The Med Tech Conference, Chicago, IL

October 10-11, 2014 10th Interventional MRI Symposium, Leipzig, Germany

October 12-16, 2014 Focused Ultrasound Foundation 4th International Symposium, Bethesda, MD

October 29, 2014 Michael J. Fox Foundation Parkinson's Disease Therapeutics Conference, New York, NY

 

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